FDA 510(k)

TULSA-PRO系统

K号: K211858 · 2022-09-06

决定日期2022-09-06

产品代码PLP

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决定实质等同

器械摘要

TULSA-PRO System is the device name listed in this FDA 510(k) record. The listed applicant is Profound Medical, Inc.. It received FDA 510(k) clearance on 2022-09-06 under 510(k) number K211858. The device is classified under product code PLP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TULSA-PRO System?

TULSA-PRO System is a medical device that received FDA 510(k) clearance on 2022-09-06. The listed applicant is Profound Medical, Inc.. The 510(k) number is K211858.

When did TULSA-PRO System receive FDA 510(k) clearance?

TULSA-PRO System received FDA 510(k) clearance on 2022-09-06, under 510(k) number K211858.

Who is the listed applicant for TULSA-PRO System?

The FDA 510(k) record lists Profound Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TULSA-PRO System?

The FDA product code for TULSA-PRO System is PLP.

列明Profound Medical, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K240296图尔萨普罗系统（Pad-105）K230692TULSA-PRO系统 K202286图尔萨-普罗系统 K191200TULSA-PRO系统

官方来源

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